The following data is part of a premarket notification filed by Next Orthosurgical with the FDA for Interform Cervical Interbody Cage System.
| Device ID | K161608 |
| 510k Number | K161608 |
| Device Name: | InterForm Cervical Interbody Cage System |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | NEXT ORTHOSURGICAL 3270 CORPORATE VIEW SUITE A Vista, CA 92081 |
| Contact | Ellen Yarnall |
| Correspondent | Ellen Yarnall NEXT ORTHOSURGICAL 3270 CORPORATE VIEW SUITE A Vista, CA 92081 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-10 |
| Decision Date | 2016-09-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840314136909 | K161608 | 000 |